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Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02178163
Recruitment Status : Recruiting
First Posted : June 30, 2014
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gerold Bepler, Barbara Ann Karmanos Cancer Institute

Brief Summary:
This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid [DNA]) and help doctors to tailor treatment to target the specific mutations.

Condition or disease Intervention/treatment Phase
Recurrent Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Other: cytology specimen collection procedure Other: laboratory biomarker analysis Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens.

SECONDARY OBJECTIVES:

I. To estimate the percentage of patients in whom genomic analysis can be performed.

II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results.

OUTLINE:

Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study will assess the percentage of advanced NSCLC patients whose tumor samples can undergo genomic analysis and in whom therapy can begin based on the results of this analysis.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study to Assess the Ability to Initiate Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Based on Genomic Analyses of Tumor Specimens.
Study Start Date : June 2014
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ancillary-Correlative (comprehensive genomic analysis)
Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, PCR, and microarray. Based on the results of the genomic analysis, patients may begin therapy.
Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Proportion of patients receiving therapy based on genomic analyses among all eligible patients [ Time Frame: Up to 21 days ]
    Will be estimated with 95% confidence interval (CI) using the Wilson's method.


Secondary Outcome Measures :
  1. Overall response rate assessed according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 2 years ]
    Response rate will be estimated with 95% Wilson's CI.

  2. Progression free survival (PFS) [ Time Frame: Time from the date of start of therapy based on genomic analysis until the date that progressive disease or death whichever is first reported, assessed up to 2 years ]
    PFS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.

  3. Overall survival (OS) [ Time Frame: From date of registration to up to 2 years ]
    Not all patients enrolled on the study will receive therapy based on genomic analyses therefore survival will be analyzed for patients who receive therapy based on genomic analyses, for patients who don't receive therapy based on genomic analyses and for the entire patient population. OS will be estimated and may also be summarized within subgroups using descriptive statistics (Kaplan and Meier) if there are sufficient data.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archival tissue for genomic analysis or are willing to undergo a new biopsy to obtain tumor tissue for genomic analysis. Patients whose tumor has already undergone genomic analysis will be eligible.
  • Zubrod performance status 0-2
  • Life expectancy >= 3 months
  • Absolute neutrophil count of > 1.5 x 10^9/L
  • Platelet count > 100,000 x 10^9/L
  • Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft-Gault formula) of > 45 mL/min
  • Serum bilirubin =< 1.5 X ULN
  • Transaminases (serum glutamic oxaloacetic transaminase [SGOT] and/or serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional ULN and alkaline phosphatase =< 2.5 times ULN, unless patient has liver metastases and the managing physician believes that the elevation in liver enzymes is only related to the liver metastases
  • Laboratory tests should be done within 30 days of enrollment on the trial
  • A biopsy of the patient's tumor for genomic profiling is required; this biopsy specimen can be an already obtained diagnostic specimen provided the patient has not received systemic therapy since the biopsy has been obtained and was obtained within 60 days of trial enrollment. The biopsy material cannot be from a tumor site that has been radiated.
  • Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines

Exclusion Criteria:

  • Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient
  • Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible
  • Pregnant or lactating women; female patients of child bearing potential will be informed that if they do enroll on a therapeutic trial, based on the genomic analyses, that they may not be able to enroll on a clinical trial if they are pregnant; all sexually active patients will be informed that patients enrolling on a therapeutic trial have to use contraceptive methods to prevent pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178163


Contacts
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Contact: Gerold Bepler, M.D. (313) 576-8665

Locations
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United States, Michigan
KCI at McLaren Bay Region Recruiting
Bay City, Michigan, United States, 48708
Contact    800-527-6266      
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Gerold Bepler, M.D.    800-527-6266    beplerg@karmanos.org   
Sub-Investigator: Amy Weise, D.O.         
Principal Investigator: Gerold Bepler, M.D., PhD.         
Sub-Investigator: Ammar Sukari, M.D.         
Sub-Investigator: Antoinette Wozniak, M.D.         
Sub-Investigator: Hirva Mamdani, M.D.         
Sub-Investigator: Misako Nagasaka, M.D.         
Sub-Investigator: Alicia Bolling-Fischer, M.D.         
Sub-Investigator: Susan Land, M.D.         
Sub-Investigator: Fulvio Lonardo, M.D.         
Sub-Investigator: David Cook, M.D.         
Sub-Investigator: Jonathan D. Abramson, M.D.         
Sub-Investigator: Shalini Thoutreddy, M.D.         
Sub-Investigator: Sharon Levandowski, M.D.         
Sub-Investigator: Youssef Hanna, M.D.         
Sub-Investigator: Samir Alsawah, M.D.         
Sub-Investigator: Faheem Ahmad, M.D.         
Sub-Investigator: Maden Arora, M.D.         
Sub-Investigator: Sai Bikkina, M.D.         
Sub-Investigator: Rana Bilbeisi, M.D,         
Sub-Investigator: Aliccia Bollig-Fischer, M.D.         
Sub-Investigator: Irene Connolly, M.D         
Sub-Investigator: Elena Coppola, M.D.         
Sub-Investigator: David Eilender, M.D.         
Sub-Investigator: Salman Fateh, M.D.         
Sub-Investigator: Lisa Galloway, M.D.         
Sub-Investigator: Sandeep Grewa, M.D.         
Sub-Investigator: Christian Hyde, M.D.         
Sub-Investigator: Ronald Kawauchi, M.D.         
Sub-Investigator: Frank Knechtl, M.D.         
Sub-Investigator: Cheryl Kovalski, M.D.         
Sub-Investigator: Elizabeth Layhe, M.D.         
Sub-Investigator: Stephanie Leslie, M.D.         
Sub-Investigator: Tallat Mahmood, M.D.         
Sub-Investigator: Mohammed Masri, M.D.         
Sub-Investigator: Seraphim Pallas, M.D.         
Sub-Investigator: Paul Porter, M.D.         
Sub-Investigator: Somdev Roy, M.D.         
Sub-Investigator: Trevor Singh, M.D.         
Sub-Investigator: Anteneh Tesfaye, M.D.         
KCI at McLaren Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact    800-527-6266      
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gerold Bepler, M.D. Barbara Ann Karmanos Cancer Institute
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Responsible Party: Gerold Bepler, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT02178163    
Other Study ID Numbers: 2014-002
NCI-2014-00913 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
W81XWH-11-1-0500 ( Other Identifier: Dept of Defense )
1402012837
2014-002 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2014    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms